Project

Symbionica is a collaborative project funded under the European Union’s Horizon 2020 research and innovation programme that focuses on the manufacturing of personalized smart endo-prosthetics and exo-prosthetics that require geometric and functional customization. The concept integrates an innovative machine performing multi-material Additive Manufacturing deposition and ablation. It exploits the process of Direct Energy Deposition (DED) for metal deposition, where focused thermal energy coming from a laser source is used to fuse metallic powders blown through a nozzle thanks to an assisting gas, and the process of Fused Deposition Modeling (FDM), in which a part is built layer-by-layer by heating and extruding a thermoplastic filament. For the first-time ablation technology complements the AM fabrication process for metal manufacturing to allow surface finishing, micro texturing and micro drilling that would be otherwise unfeasible in traditional machines. Moreover, Symbionica presents an advanced closed loop control methodology for product and process quality monitoring.

The Symbionica machine presents a platform with 5 degrees of freedom, a Z axis with 1200 mm linear travel, X and Y axes with linear travel of 800 mm, a rototilting table with Ø600 mm. The whole cabin has a 4000x4000x3000 mm max dimensions with a completely sealing for inert environment.

Current generation implants have been redesigned and optimized for Symbionica processes. All these components can be fully customised in their functionalities during the design and manufacturing stages. The prosthesis can be specifically created for each patient directly from a 3D computer model resulting from post processing of the patient’s scan, which will be completed by additional information related to the patient’s height, weight, physical training and habits.

The demonstrators use cases of the projects are respectively a Dorso Lumbar Body Cage (Sintea Plustek), a multi-material knee prosthesis (Medacta International SA) and hip implant (Medacta International SA) made in Cobalt-Chrome, Titanium and PEEK and a multi-material prosthetic foot (Ottobock).

Symbionica machine concept

Head of Symbionica machine

Symbionica objective is to make technically feasible and economically sustainable the production of orthopaedic smart implants/prosthesis with a level of customization never seen before: geometrical and morphological customization to tailor the implant to patient interfaces for endo-, exo- and hybrid implants made in multiple materials; functional customization to adapt prosthesis dynamic and static behaviour to patient needs (responsiveness to loads, condition based drug delivery, etc.) across the patient life.

Four demo certifiable prosthesis, belonging to different families, manufactured with the hereinabove machine and reengineered in order to satisfy the maximum level of customization to patient specific needs, including integration of new sensors;

A novel Cooperative design platform including the hereinabove CAD templates and interfaces with medical diagnostics (CT), with CAD/CAM and CAPP system of suppliers involved. This will allow involving all relevant stakeholders: doctors, patients prosthesis (sub)suppliers in the development of a bionic prosthetic solution fully tailored on the patient expectations and physical characteristics.

A device, “Bionic Through-life Sensing System” able to collect data from hereinabove sensors and a SW able to monitor/analyse them providing useful reports to patient helpful e.g. to plan physiotherapy, to medical staff and to prosthesis designers for further improvements

The technical objectives of the Symbionica project are grouped into four key innovation actions:

a) Innovation action for products:

Symbionica will enable the design and manufacturing of a new generation of prosthetics whose design and structure is currently out of the feasibility ranges of both conventional technologies (which is unfit to manage complex reticular shapes and multi-material / functionally graded structures) and current Additive Manufacturing (which is unfit to manage multiple dimensions parts and high production rates):

One of a kind parts with different functions (e.g. resistance, fixing, osteointegrability) and different materials (Ti, Ti-Al-V, Carbon or Glass Fibre composite, UHMWPE, Peek) in complex shapes and surface patterning;

Fully personalized prosthesis: an accurate patient-specific implants produced using the 3D scan data can reduce the removal of healthy bone, eliminate the need for bone grafting, promote effective planning of implantation/surgery, shorten the time of anaesthesia, reduce criticalities of post-surgery phase, reduce patient learning phase, etc;

All the products will benefit from closed loop controlled and certified quality tracking the effect of the process on final performance e.g. change of physical state in materials (fusion/melting, solidification/curing) that, in turn, may lead to a modification of micro-or nano-scale structure of the material itself.

b) Innovation action for processes:

Symbionica will combine different technologies in a single machine to deliver true-net-shape products through a real-one-step process with an unprecedented material usage efficiency (-75% vs. SoA) and energy efficiency (-40% vs. current processes);

Symbionica will implement an advanced hybrid 3D laser scanner that, combined with a novel laser source system, will support different laser based additive and subtractive technologies. For the first time ablation technology will complement the AM fabrication process for metal and composite manufacturing to allow surface finishing, micro texturing and micro holes that would be otherwise unfeasible in one processing step;

Symbionica will be equipped with an innovative flexible revolver head that will enable blending multiple powders and extruding different materials and with different particles dimensions (micro and nano powders) to enhance usage flexibility;

Symbionica machine and software infrastructure will perform a closed-loop monitoring of the process that will lead to parts that are always right the first time (zero defect manufacturing) thanks to a sophisticated sensing system (camera and spectroscopy integrated system) and process parameters corrections elaborated and implemented at NC level.

c) Innovation action for equipment:

Symbionica will combine fast mechatronics, additive and subtractive laser processing in the most flexible AM machine ever built before, with a redundant structure to accommodate extremely variable working cubes and deposition areas (from 100x100x100 mm to 1’500×2’000×2’000 mm);

Symbionica will enable the integration of multiple AM technologies in one single machine to combine the most productive alternative with the most precise one with zero set-up time and zero material waste;

Symbionica will offer world class efficiency: super light structure, energy efficient process modulation, high power with high beam quality laser source that allows power densities on the working area currently achievable with higher power lasers, fully adaptive process planning to minimize any energy loss;

Symbionica will minimize powder losses by guaranteeing a controlled atmosphere in the operative region thanks to a shielded working space that encapsulates all ejected powders and protects them from oxygen contact;

Symbionica will implement a software infrastructure with the first working exploitation of a completely closed automatic in line CAx chain bound to the CNC to select the Best Available Processing Strategy and machine settings;

Symbionica will offer the highest throughput rate (>150 cm3/h; up to 500 cm3/h) with unprecedented surface quality (submicron rugosity) thanks to the combination of two highly efficient laser sources (one CW for the sintering of metal powders and one pulsed for precise ablation and surface smoothing) and a fast scanning head;

All the aforementioned features will severely reduce the manufacturing costs of prosthesis, thus contributing to make the customization process cost-effective

d) Innovation action for value chain:

Symbionica will support the co-engineering process across the supply by enabling data integration and exchange along with methodologies and tools for supporting the design, manufacturing and logistics of complex assemblies;

Symbionica will rationalize under-utilized expensive distribution centres as a result of a very efficient cooperative manufacturing and synchronized logistics between the players of the manufacturing chain;

Symbionica will drastically reduce excess inventory by manufacturing components and final products on demand;

Symbionica will offer a fast and efficient prosthetics adaptation process on the patient requirements once delivered so to avoid post sailing modifications.

Symbionica focuses on Orthopaedic Prosthetics whose specific market is expected to reach USD 38.75 billion by 2020 at an estimated CAGR of 9.3% from 2014 to 2020. The share of high added value products is significant: for example the design, manufacturing and fitting of artificial limbs, which typically cost between $10’000 and $85’000, cover a market estimated to reach $15.3 billion in 2015 and grow to $23.5 billion by 2017. Motivations behind the growth trend are the ageing population and the rising prevalence of health issues such as diabetes, as well as cancer and degenerative joint diseases including arthritis and osteoporosis.
The Orthopaedic Prosthetics value chain is much more complex and multidisciplinary than at one’s first thought, as it includes hospital, orthopaedist, surgeon, patient, material suppliers, prosthesis designer, prosthesis integrators, prosthesis components manufacturer, sterile packaging providers, sensors developers, IT companies for data and design management, supplier of diagnostic tools and other devices.
From the product technology point of view, Orthopaedic Prosthetics are evolving fast, integrating new knowledge and multidisciplinary technologies in order to gradually make any human being with illness, bone anomaly or amputation comfortable in conducting a normal life in modern society: for instance myoelectric actuators that involve the usage of electrical signals from the patient’s arm or leg muscles to move the upper limbs, or embedded sensors that can monitor the prosthetics functionalities and performance. Making patients confident again with their body requires a profound personalization process where any components of the prosthetics are fully customised to the patient needs. This is not limited to the physical features, but includes the ways the patient relates to the prosthetics in terms of: how easy is to learn to use it; how few are the repairs or replacement interventions; how comfortable and easy it is to put on and take off, how strong yet lightweight, easily adjustable, easy to clean it is and how natural it looks.
Hence, considering the innovation in manufacturing processes, Multi Material Additive Manufacturing (MM-AM) has the potential for improving the lives of a larger number of patients, offering breakthrough opportunities:

capability to process all the different materials use for prosthesis (i.e. Ti, Peek, UHMWPE, GF and CF composites) even in one single process step, cutting the production cost of customised solutions by 50% (from 5x to 2.5x);

integration of functions through MM and functional grading, adding value to the final product (e.g. prostheses manufactured to be enriched with controlled drugs release mechanisms; autonomous, battery-less sensing systems);

capability to combine additive and subtractive laser processing tasks to reduce the production steps and thus to decrease the lead time to fit surgery and medical treatment planning.

A) BIONIC PROSTHETICS

A bionic prosthetics is an assembly of various parts. The liner (in gel, polyurethane or silicone) connects the residual limb to the bionic prosthesis; it usually covers the Titanium implant protruding from the residual limb (nested to the bone) and the sensors, which are attached to the muscles. At the same time the gel envelope works as a cushion between the hard material of the prosthesis and the skin. Endo-prostheses to be nested to bones must integrate quickly with the newly formed bony tissue, through arthrodesis, the fusion between endoprosthesis and bones.

Usually, such objective is for example achieved by the use of osteoconductive materials, which allow the rooting and proliferation of the bone tissue. The best solutions are represented by Titanium or Titanium alloys with Aluminium-Vanadium or Niobium-Zirconium. Surfaces with morphologies suitable for the incorporation and/or mechanical grip of the bone tissue are also used. The best solutions adopted so far consist in manufacturing rough surfaces, obtained by plasma pore technique or by sintering metal micro-spheres. The liner is accommodated in the socket, which is the part of the prosthesis hosting the limb. Attached to the socket there is the pylon, which is the structural part of the prosthesis and the one which is connected to spring, motors, jigs and sensors to ensure a smooth motion across multiple degrees of freedom. The actuation and sensing system is controlled by a micro-processor, which adapts the prosthesis operating mode to the human tasks and environment features. The mechatronics of the prosthesis ends with the hand- or foot-like silicon glove.

B) ENDOPROSTHETICS

Smart endoprosthetics are inner implants made of smart materials and a set of sensors. Smart materials enable a change of prosthetic behaviour as a result of external stimuli, such as stress, temperature, moisture, pH, electric or magnetic fields. The sensors should be able to detect and measure variables of various natures (e.g. mechanical, thermal, chemical, electrical, etc.) and to enable changes: for example applying forces or pressures, inducing strain or displacement, releasing chemical agents or drugs, creating electrical voltage or current.

To implement such capabilities, endoprosthesis should be made of material highly efficient, bio-compatible, implantable and capable to act as host-material, capable of embedding micro-sensors and actuators without impairing their own intrinsic performances. As an example, smart materials may aid in avoiding interfacial atrophy, which is a common cause of prosthetic failure. Besides, smart endoprosthesis, should be extremely patient-customised in size, shape and functionality. To add such a feature, they should be produced through automatic additive/subtractive technologies, fed by CT or NMR files, compatible with different kinds of materials (metals, metal alloys, polymers, carbon and glass reinforced polymers), manufactured so as they can host micro sensors and micro actuators and suited to produce micro or nano devices.

C) EXO-PROSTHETICS

Smart exo-prostethics including wearable sensors, support devices (tutors) and corsets represent a third category that could profoundly benefit from advanced personalization and new manufacturing technologies. Conventional exo-prosthesis and tutors usually consist in passive devices (supports, tutors, corsets) made of fabric or leather reinforced/stiffened with metallic or polymeric inserts. They are often adopted at the initial stages of functional degeneration (mainly in the field of orthopaedics) with the aim of avoiding a possible subsequent surgery, or after surgery. In the latter case, they should provide a temporary support during rehabilitation. At any rate, they should be – at least – light, not too much cumbersome, totally compliant with patient’s anatomy and able to follow possible growth (in case of paediatric patients); besides, they should able to adapt performances (e.g. stiffness) to possible disease evolution. In reality, very often conventional exo-prostheses are heavy, bulky, cumbersome, and their degree of customization is limited. As a result, they very much impair patient’s performances and daily quality of life. To reduce weight and dimensions, smart exo-prostheses should exploit multi functionality. Besides, to implement smart features (e.g. automatic and continuous customization  morphing/adaptivity, capability to comply with anatomy growth and capability to adapt performances e.g. strength/stiffness to requirements evolution), the exo-prostheses should be made of polymers or reinforced polymers, able to embed sensors (of force, pressure, strain, displacement) and actuators (to modify shape, size, strength, stiffness).

A) Bionic prosthetics

B) Endoprostethics

C) Exoprosthetics

In order to guarantee the achievement of Symbionica objectives and to efficiently manage related project complexity, a coherent work plan, over 3 years, has been developed. It is organized in 11 work packages clustered in Project Management, Scientific and Technical, Demonstration and Dissemination and Exploitation activities. Particularly, the RTD activities will map the Symbionica solution development lifecycle from the product and technologies design phases to processes and equipment design phases through to the data acquisition, control and optimization phases. Specifically:

PROJECT MANAGEMENT

WP1 aims at managing the overall project activities.

SCIENTIFIC AND TECHNICAL ACTIVITIES

WP2 refers to the advanced prosthetics design and the development of Co-Engineering Platform for modelling and engineering the next generation of personalized products design by technologies.

WP3 covers the activity of process design and planning where the actual manufacturing process is developed on the basis of the various available technologies and the products and production requirements.

WP4 deals with the design and configuration of the laser source and the 3D scanner to be nested into Symbionica machine.

WP5 regards the design and configuration of the Symbionica machine including the lightweight gantry and the PKM, which will host the laser head developed in WP4.

WP6 addresses the design of the sensing system, including the complex vision infrastructure and 3D infrared scanner.

WP7 refers to the CAx software infrastructure development to support the closed loop monitoring, adaptation and optimization works by determining the process and machine adaptations/compensations to be executed to match the part and production quality requirements.

WP8 pertains to the Control design that is responsible for operatively realizing the adaptations identified by means of sensing system.

WP9 relates with the Symbionica solution integration and overall monitoring and optimization where all the aspects addressed at local level (e.g. process, machine and powder) and at supply chain level are investigated and enhanced under a hierarchical optimization strategy selecting dynamically the energy, productivity and resource efficiency trade-offs and planning the strategies over the time.

DEMONSTRATION, DISSEMINATION AND EXPLOITATION

WP10 refers respectively to the development of one lab and one pilot demonstrators for the medtech industry.

WP11 ascertains an extensive dissemination and exploitation activities with the aim of boosting Symbionica industrial solutions in future industrial practice.

Ethics: Symbionica team will work in permanent respect of Charter of Fundamental Rights of the EU. This statement will be continuously guaranteed, in conformity to existing legislation and regulations, over the project life

Carsten’s Story

With his busy schedule, Carsten doesn’t have time to worry about mobility. With his Harmony below knee vacuum system he is able to run, climb, and sail.

Randy’s Story

Four years after being diagnosed with bone cancer, Randy Herlein got a lower limb endoprosthetics implant and embarked on a lifelong dream, hiking the Grand Canyon. It took Herlein and his team two days and a combined 20 hours of hiking to get to the bottom, where they spent two nights in the Bright Angel campground.

Ann’s Story

Ann was a dedicated athlete with 25 marathons under her belt. She often ran with discomfort because, as she says, “back pain had always been a part of my life.” Eventually, her symptoms became so debilitating that she couldn’t train. She’s back again enjoying life and marathons after her spinal implant surgery.

Andrew’s Story

Even though he’s retired from the Air Force, Lt. Col. (Ret.) Andrew Lourake is still full speed ahead – in the air, on land and in water, thanks to the Ottobock X3 prosthetic leg.